Z-0811-2017Class II

MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55 S61CM D66CM GLOBAL Catalog # 990061-055-000 Is designed...

Name: Z-0811-2017 MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55 S61CM D66CM GLOBAL Catalog # 990061-055-000 Is designed...
Creator: Oscor, Inc.
Published: 2016-10-05
License: https://open.fda.gov/license/

Oscor Inc. / initiated 2016-10-05 / Terminated / root cause: manufacturing process

FDA source

Oscor, Inc. began a recall of MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55 S61CM D66CM GLOBAL Catalog # 990061-055-000 Is designed to facilitate the introduction of catheters to any... on 2016-10-05. FDA classified it as Class II and gives the reason as "Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0811-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-05
Posted: 2016-12-19
Terminated: 2019-07-26
Recalling firm: Oscor Inc.
Product: MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55 S61CM D66CM GLOBAL Catalog # 990061-055-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Product code: DYB Introducer, Catheter
Reason for recall: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Oscor sent two(2) Product Recall notifications: -HOSPITALS: Immediately check your inventory to confirm that you do or do not have units from these lot(s) in your possession. Identify and set aside any unit from the identified lot in a manner that ensures the affected product will not be used. Check all storage and usage. Review, complete, sign and return the enclosed Acknowledgement Form attached in the letter, directly to Oscor Inc. at the fax number or e-mail on the form, for immediate replacement (as applicable). Who to call: Please call Oscor Inc. Customer Service Department at 727-937-2511 or email [email protected] Hours of operations: Monday to Friday from 8:30AM to 5:30PM Eastern Time. - DISTRIBUTORS: Immediately check your inventory to confirm that you do or do not have units from these lot(s) in your possession. Identify and set aside any unit from the identified lot in a manner that ensures the affected product will not be used. Check all storage and usage. Please pull a list of the hospitals (end user) impacted by the affected lots and retrieve inventory for replacement, if available. Review, complete, sign and return the enclosed Acknowledgement Form (Exhibit A) attached in this letter, directly to Oscor Inc. at the fax number or e-mail on the form, for immediate replacement (as applicable). Who to call: Please call Oscor Inc. Customer Service Department at 727-937-2511 or email [email protected] Hours of operation: Monday to Friday from 8:30AM to 5:30PM Eastern Standard Time.
Quantity in commerce: 566
Distribution: Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM
Product codes and lots: Lot #'s: C1-08604 Exp. February 20, 2017, C1-08938Exp. May 19, 2017, C1-08986 Exp. June 1, 2017, OR-04488 Exp. June 30, 2017, C1-09756 Exp. February 18, 2018, C1-09757 Exp. February 18, 2018, OR-04633 Exp. March 10, 2018, C1-10118 Exp. April 17, 2018, C1-10119 Exp. April 17, 2018, C1-10147 Exp. April 23, 2018, and C1-12525 Exp. May 17, 2019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0811-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0790-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0791-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0792-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0793-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0794-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0795-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0796-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0797-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0798-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0799-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0800-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0801-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0802-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0803-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0804-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0805-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0806-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0807-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0808-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0809-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0810-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0811-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0812-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0813-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0814-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0815-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0816-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0817-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0818-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0819-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19

Product code DYB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)